Clinical Trials Coordinator

We are seeking an organised and passionate individual to join our paediatric Neurology department as a Clinical Trials Coordinator. The post holder will be responsible for a portfolio of clinical trials, managing individual trial set up processes, from initiation to completion, in a timely and efficient manner. Be an integral part of the clinical trials team in Paediatric Neurology. Ensuring all trials are opened to a robust time frame, enabling novel treatments/ investigations to be available to patients. This is a crucial role in ensuring trials involving children and young people treated within Paediatric Neurology at Cambridge University Hospitals NHS Foundation Trust (CUH) are properly conducted according to Good Clinical Practice (GCP), Research Governance Framework and are compliant with the EU / UK directive for clinical trials. The Paediatric Neurology team is part of Women's and Children's Services at CUH, currently running a number of national and international clinical trials and serves the population of the East of England. The team are looking to support access to research and trials and this role is crucial to that. The post is part of a small team responsible for new and existing clinical trials and clinical research projects within the Paediatric Neurology portfolio, including Clinical Trials of Investigational Medicinal Products., The key job functions of the Clinical Trials Coordinator are:

• To facilitate and co-ordinate the set-up and conduct of clinical trials and/or clinical studies working closely with Principal Investigators and their teams, research nurses and trials assistants.
• Ensuring that all data is collected following the appropriate protocols.
• To work in compliance with the International Conference on Harmonisation Good Clinical Practice Guidelines (ICH-GCP), the NHS Research Governance Framework for Health & Social Care and, in the case of a CTIMP, in compliance with the Medicines for Human Use (Clinical Trials) Regulations 2004.
• The Clinical Trials Coordinator is responsible alongside PIs for implementation of GCP, undertaking and supporting ethical committee applications for local approval, R&D submissions and Serious Adverse Events (SAE) reporting.
• This post is also responsible for document control and dissemination, including keeping appropriate records; protocol review as part of studies and the development and maintenance of all trial site files relating to studies. In the event of a statutory GCP inspection, the Clinical Trials Coordinator would assume responsibility for preparation of all documentation and arrangements for the inspection in support of the relevant Principal Investigators (PIs)
• The Trials Coordinator will work closely with the Paediatric Neurology Research Lead, PIs, Research Nurses and Trials Assistants to support staff working on research and trials.
  
  Our Trust
Cambridge University Hospitals (CUH) NHS Foundation Trust comprises Addenbrooke's Hospital and the Rosie Hospital in Cambridge. With over 13,000 staff and over 1100 beds the priorities of the Trust focus on a quality service which is all about people - patients, staff and partners. Recognised as providing 'outstanding' care to our patients and rated 'Good' overall by the Care Quality Commissioner, is testament to the skill and dedication of the people who work here. CUH's values - Together - Safe, Kind, Excellent - are at the heart of patient care, defining the way all staff work and behave. The Trust provides accessible high-quality healthcare for the local people of Cambridge, together with specialist services, dealing with rare or complex conditions for a regional, national and international population. CUH is committed to promoting a diverse and inclusive community - a place where we can all be ourselves. We value our differences and fully advocate and support an inclusive working environment where every individual can fulfil their potential. We want to ensure our people are truly representative of all the communities that we serve. We welcome applications for all positions in the organisation irrespective of people's age, disability, ethnicity, race, nationality, gender identity, sex, sexual orientation, religion or belief, marriage and civil partnership status, or pregnancy and maternity status or social economic background.